Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Original IDE Cohort (Melody IDE)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 21, 2008
Last updated: October 31, 2016
Last verified: October 2016
No Study Results Posted on ClinicalTrials.gov for this Study
|Study Status:||This study is ongoing, but not recruiting participants.|
|Estimated Study Completion Date:||January 2020|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Cheatham JP, Hellenbrand WE, Zahn EM, Jones TK, Berman DP, Vincent JA, McElhinney DB. Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial. Circulation. 2015 Jun 2;131(22):1960-70. doi: 10.1161/CIRCULATIONAHA.114.013588.
McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013 Jun;6(3):292-300. doi: 10.1161/CIRCINTERVENTIONS.112.000087.
McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. doi: 10.1161/CIRCINTERVENTIONS.111.965616.